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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. HUBER SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. HUBER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2017
Event Type  malfunction  
Event Description
Huber needle bent.
 
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Brand NameHUBER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key7045348
MDR Text Key92519630
Report Number7045348
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2017
Event Location Hospital
Date Report to Manufacturer10/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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